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Post Marketing Plan. Earl Sands, M.D. Vice President and Chief Medical Officer US Research and Development Solvay Pharmaceuticals. Post Marketing Plan Agenda. RiskMAP PULZIUM ® Observational Study – “POST”. RiskMAP Development. Inclusion of multiple stakeholders in US and EU

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Post marketing plan

Post Marketing Plan

Earl Sands, M.D.

Vice President and Chief Medical Officer US Research and Development

Solvay Pharmaceuticals


Post marketing plan agenda
Post Marketing Plan Agenda

  • RiskMAP

  • PULZIUM® Observational Study – “POST”


Riskmap development
RiskMAP Development

  • Inclusion of multiple stakeholders in US and EU

    • Physicians, nurses and pharmacists

  • Pretesting via user panels in US and EU

    • Iterative process; revisions made based on feedback

  • Objective: to provide the optimal benefit/risk balance for tedisamil by ensuring product use consistent with prescribing information

    • Minimizing risks

    • Preserving benefits


Riskmap objectives
RiskMAP Objectives

Align usage with the label

  • Appropriate clinical setting (ECG monitoring and staff training)

  • Appropriate patient selection

  • Correct dose and administration

  • Monitoring for a minimum of 2 hrs from the start of infusion and until QTc becomes normal


Risks to be minimized
Risks to be Minimized

  • As with all antiarrhythmic drugs, tedisamil use has risks

    • Torsade de Pointes

    • Bradycardia

    • Hypotension

  • These risks can be minimized by addressing the potential contributory factors/causes:

    • Miscalculation/misadministration of dose


Riskmap tools
RiskMAP Tools

  • Labeling

    • Comprehensive, first line of risk communication

    • Gender-specific, detailed height and weight-based dosing chart

  • Targeted education and outreach

    • A number of tools will be used in educating physicians and HCPs, which also have a reminder function and are therefore listed in the section below

    • HCP website

  • Reminder systems

    • Physician checklist

    • Infusion bag stickers

    • Arrhythmia diagnostic guide

    • QTc guide

    • Dose guide and calculator

    • Administration and monitoring guide



Gender specific dosing charts
Gender-specific Dosing Charts

  • Separate charts for males and females, which provide dose volume based on weight and height

Height

Height

Weight

Weight


Outline of the two bag regimen
Outline of the Two-Bag Regimen

Infusion:

Step1: Infuse Bag 1 at 10 ml / min over 10 min

Step 2: Infuse Bag 1 at 5 ml / min over 20 min

Bag 1

Bag 2

100 ml

10 min

100 ml

20 min

3

-

way

-

cock

Pump



Post marketing plan1

Post Marketing Plan

Earl Sands, M.D.

Vice President and Chief Medical Officer US Research and Development

Solvay Pharmaceuticals


Post marketing plan agenda1
Post Marketing Plan Agenda

  • RiskMAP

  • PULZIUM® Observational Study – “POST”


Riskmap development1
RiskMAP Development

  • Inclusion of multiple stakeholders in US and EU

    • Physicians, nurses and pharmacists

  • Pretesting via user panels in US and EU

    • Iterative process; revisions made based on feedback

  • Objective: to provide the optimal benefit/risk balance for tedisamil by ensuring product use consistent with prescribing information

    • Minimizing risks

    • Preserving benefits


Riskmap objectives1
RiskMAP Objectives

Align usage with the label

  • Appropriate clinical setting (ECG monitoring and staff training)

  • Appropriate patient selection

  • Correct dose and administration

  • Monitoring for a minimum of 2 hrs from the start of infusion and until QTc becomes normal


Risks to be minimized1
Risks to be Minimized

  • As with all antiarrhythmic drugs, tedisamil use has risks

    • Torsade de Pointes

    • Bradycardia

    • Hypotension

  • These risks can be minimized by addressing the potential contributory factors/causes:

    • Miscalculation/misadministration of dose


Riskmap tools1
RiskMAP Tools

  • Labeling

    • Comprehensive, first line of risk communication

    • Gender-specific, detailed height and weight-based dosing chart

  • Targeted education and outreach

    • A number of tools will be used in educating physicians and HCPs, which also have a reminder function and are therefore listed in the section below

    • HCP website

  • Reminder systems

    • Physician checklist

    • Infusion bag stickers

    • Arrhythmia diagnostic guide

    • QTc guide

    • Dose guide and calculator

    • Administration and monitoring guide



Gender specific dosing charts1
Gender-specific Dosing Charts

  • Separate charts for males and females, which provide dose volume based on weight and height

Height

Height

Weight

Weight


Outline of the two bag regimen1
Outline of the Two-Bag Regimen

Infusion:

Step1: Infuse Bag 1 at 10 ml / min over 10 min

Step 2: Infuse Bag 1 at 5 ml / min over 20 min

Bag 1

Bag 2

100 ml

10 min

100 ml

20 min

3

-

way

-

cock

Pump



Pulzium observational study post
PULZIUM® Observational Study – “POST”

  • A prospective observational study

    • 1200 - 2000 patients

    • demographic, prescribing and adverse event data

    • 120 geographically diverse sites

  • The aim of the study would be to generate real-world benefit/risk data on tedisamil

    • detailed, real-time safety data

    • evaluating safety and efficacy in ethnic minorities, i.e. African-Americans, Hispanics, etc.

    • evaluating the success of the RiskMAP as a whole


Pulzium observational study
PULZIUM® Observational Study

  • The study would be under the auspices of an independent DSMB

  • Data evaluated quarterly and every 300 treated patients

  • Periodic and real-time updates to FDA as necessary to meet the new REMS criteria*

*Source: Title II FDA Revitalization Act. Subtitle A – Risk Evaluation and Mitigation Strategy(from http://help.senate.gov/minpress/2007_04_18 accessed on 9-12-07


Post marketing plan conclusions
Post Marketing Plan Conclusions

  • Targeted interventions to address known risks

  • Key objective – aligning usage with label

  • Proactive, comprehensive program

    • Built-in redundancy to improve effectiveness

  • Consistent with existing clinical practice

  • Sponsor is committed to evaluation and program revision, as needed

  • Robust observational study to reinforce a positive benefit/risk profile


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